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GMP Lapses At Biocon’s Indian Site – Jitters for Neulasta Biosimilar Plans?

 
• By Anju Ghangurde

Biocon’s facility in Bangalore, India, has failed to pass muster with the US FDA, raising questions on whether this could result in a pushback of commercialization timelines for partner Mylan’s biosimilar pegfilgrastim in the US. The European regulator has also not cleared the Bangalore site. 

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BIOCON'S BANGALORE SITE HAS NOT MADE THE COMPLIANCE CUT YET

Biocon’s shares were under pressure on Indian bourses after the company’s sterile drug product manufacturing facility in Bangalore failed to make the compliance cut in a pre-approval inspection by the US FDA. Compliance deviations at the Bangalore site were also flagged up by the European regulator, dealing a double blow to the Indian firm.

The disappointing compliance outcome comes at a critical juncture in the run up to the June 4 FDA action date for Biocon Ltd

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